EXALT Model D Single-Use Duodenoscope recall
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN #…
Why was EXALT Model D Single-Use Duodenoscope recalled?
Poor image quality due to fluid ingress in the lens.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 08714729993605, Outer box UPN# M00542421, Inner box UPN # M00542420, Lot / Batch # 31118200, 31537337, 31118202, 31538040, 31129470, 31544823, 31145980, 31544825, 31150536, 31590918, 31150537, 31591865, 31150538, 31607291, 31175587, 31619981, 31193809, 31627631, 31193810, 31636279, 31232040, 31643793, 31239963, 31676406, 31248263, 31683921, 31251918, 31692257, 31269307, 31697145, 31275008, 31706116, 31283026, 31710191, 31305347, 31718478, 31322088, 31726052, 31334176, 31729292,31338402, 31734350, 31347461, 31738755, 31348990, 31738756, 31357937, 31754162, 31360721, 31762358, 31366683, 31764634, 31373783, 31767053, 31409362, 31774421, 31416272, 31783669, 31424741, 31826665, 31429697, 31828975, 31430274, 31846317, 31440192, 31858409, 31447120, 31874720, 31454624, 31915555, 31458181, 31939608, 31462880, 32033589, 31472232, 32047032, 31474875, 32082692, 31537336. UDI-DI (GTIN): 08714729995753, Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0, Lot /Batch # 31118201, 31331654 31129503, 31817723, 31265893.
- Product
- EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN #…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- US: 5,709 devices & OUS: 180 devices
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA VT, WA, WI & WV. The countries of Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, Switzerland.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)